Maij-Weggen, J.

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European Communitiestlilit r:.' ,l ;1./rriilr,' '  i;-iEUROPEAN PARLIAhdEb{TWbrking llocuments1979 - 198018 March l9t0 DOCUMET{T r-834/79Reportdrawn up on behalf of the Cornmittee on the Environment. Public Health andConsumer Protectionon the proposal from the Corrmission of the European Cornrnunities tothe Council (Doc. l-zl\hg) f,or a directive arnending for theseventh time the Dheetive of 23 october 1962 on the approximation ofthe rules of the Member states concerning the colouring mattersauthorized  for use in foodstuffs intended for hurnan consumptionRapporteur: Mrs J. MAU-WEGGENrglish Edition PE 62.070/fin.By letter  of  9 August 1979 the President of the council of  theEuropean Communitiesr requested the European Parliament to deliver  anopinion on the proposal from the Commisgion of  the European Communitiesto the Council for  a Directive  amending for  the seventh tine  the Directiveof  23 October. L962 on the approximation of  the rules of the l"lember Statesconcerning colouring matterg authorized for  use in  foodstuffs intendedfor  human consumption (Doc. 1-273/79).The president of  the European Parliament referred this  proposaL tothe Committee on the Envlronment, Publ-ic Health and consumer Protectionon 24 September L979,On 25 September 1979 the Committee on the Environment, Public Healthand Coneumer Protection appointed Mrs Maij-Weggen  rapporteur.It  considered thie  propoeal at  its  meetinge of  23 November L979,25 January 1980 and 28 February 1986 and at the last  of  theee meetingsadopted the motion for  a resolution and attached explanatory  statementunanimouEly but for  two votes against.PreEent: Mr Collins,  chairman; Mr Johnson, vice-chairman;Mrs Vfeber, vice-chairman; Mls Maij-Weggen,  raPporteux; l4r Ceravolo(deputizing for Mr Segre), Mr Ghergo, Mies Hooper, l4r Mertens,Mr Muntingh, Mr Ne\^tton Dunn, Mrg Schl-eicher,  Mrs Seibel-Emmerling,Mrs SquarclaluPi.-3- PE 62.O7O/fin.CONTENTSA. MOTION FOR A RESOLUTION.EXPLANATORY  STATEMENT.Dr-a59-4- PE 62.07O/tin.The Committee on the Environment, Public Health and Consumer Protectionhereby submitE to the EuroPean Parliament, the following motion for  aresolution,  together with explanatory statement:II{OTION .FOR A RESOLUTIONembodying the opinion of the European Parliament on the proposal from theCommission of the European Communities  to  the Councit for  a Directive amendingfor  the seventh time the Directive of  23 October L962 oa the approximationof the rulee of the Member Statee concerning colouring matters authorized foruse in  foodetuffs Intended for  human consulnptlonThe Europetn Pqlliam€nt,-  havlng regard to  the proposal frorn the Cornmigeion of the European comrnunitiesto the counciII,-  havi,ng been conEulted by the council purauant to Article  100 of the EEcTreaty (Doc. L-273/79),-  having regard to the report by its  Comnittee on the Envlronment, PublicHealth and consumer Protection (Doc.I-834/79r,I.  Weleomes the Commission'e propoeal, to tighten up further  the rulesgoverning authorlzed colouring mattcrs in  foodstuffg intended forhuman consunqltlon;2.  Takcg thr  vlcw that  the ugc of  chemical colouring mattere anddlluents for  colouring mattere in  foodetuffs ehould be restrictedrather than encouragcd, and stessee that  theee eubstances ehould onlybe authorized when thelr  use is  necessary for  technical and economicreaons, and if  they have been scientifically  shown to be safe;3.  Approves the temporary use of carrageenan (n z!o7) and gum arabic(E 4f4) as diluents  for  carotenoid colouring matters (E 160 andE 161), since these substances  already feature on the Community listof perndtted emulsifiers,  stabilizers,  thickeners and jeLling  agents;4.  urges, however, that before the uee of gum arabic iE definitivelyapproved, further  regearch ehoutd be conducted, since this  subetancels  belLeved to possess allergenie propert Lesiz5.  Hopcs that  the proposcd prohlbitlon  of Yellow 2G, about whichreservatLonl  wcro cxprceeed at an aarlLer date, will  come intoforce as qulckl.y as possiblei''|- OJ No. C zOL, 10.8.L979, P. 132 wHo liet  of foodstuff additives No 5, L976, pp. 331 ff'-  PE 62.O7O/tLn.6.  T'akes ttie vier* that  the uge of griLliant  BLue in  foodgtuffs,  althoughtoxicologiealty  acceptable, is  of doubtful val-idity,  because thesubstance cannot be stated to be completely safe, and because thetechnical and economic need to use it  has been ineufficientlydemonstrated;7.  Is prepared to aLlow the use of thie  substance in  limited  guantitieeif  the economie and technical need can b€ s6leoif,ica'11y demonstEted, andaeks the commiseion to  submit more detailed proposals to Parl-iamentin  tiris  connec'Ei,onig.  Requests .{:he commiseion, when subnitting direetlves  and amendmentato directives  of, this  kind in  future,  not to confine itself  tOtoxicolog:.cal :factore but to take allergenic proP€rties and technicaLancl eqrf,noni"c a:rgunrerrte into  account as weLl;L  Rr.rgi:eots the Crlmnission to determine to what extent it  is  poseiblefor product lahErl-e to  spacify hthat colouring matters have beenusediLO. Considers that  in view of the large number of  changes to  the originaldirective  of  l",gd2, an overall  vj-ew of  the present situation  is  urgentlyrequired and requeste the commission to Provide Parliament and the commiittoe  ree;lonsiible with guch an overall .view trhen it  next eubmits proPoE-a1e for  the amendment of thlE directive;lln  AFproves Lhe proposal, Subject to the following amcndments pureuantto Article  L49(2) of the EEC Treaty.-6- PE 62.O7O/tLn.T EXT PROPOSID  IJY THE COI\,IMISSIO.N  OFTHE EUROPEAN  CONIMUNITIES'Having regard to the Treaty establishing the European Economic Communlty, and in partlcular  Article  100 thereof,Having regard to the proposal from theCommi ssl on,Having regard to the opinion of  thefi:uropean  Pa rJ.iament,Havlng regard to  ilre opinion of  theEconomlc and Social Committee,Whereas Annex II  to the council Directive of  23 October 1962 on the approximationof the ruLes of the Member States con_ eerning the colouring matters authorized for  ure in  foodstuffe intended for  human con_lu4ption, as laet  amended by Directive 7A/L11/EEI,  lays down a list  ol  colouring mattars which may temporarily be authorizCd by the Member States iWhereas ln  tfre light  of present-dayrequirements regardlng the safety ln  use of colouring mattere, yelLow 2c ehouLd no longer be pcrmltted for  uee in  foodgtuffe;Whereas the prohibltlon  so requlred should be given effect  under conditione whichensure the protection of publlc  health,whi-le avolding ae far  ae possible a1l disruption of a technological and economicr)aturetWhereas having regard to the moet recent scientific  and toxicoJ.ogical informationon Brilliant  Blue FCF it  is p ossible to authorize this  coLouring matter within the Community;Whereas the uge of the carotenoLd colour_ ing matters E lGO and E 16l ie  facllitated by their  dLlutlon wi.th carrlgecnan (E 407)and gum arablc  (8414);Wheraas thc Commtegion ig  reviewlng thcuse of all  aubstances  used for  dllutlngand dlesolvlng colourlng matters ancl ii is  therefore nog possible to take a final decision on whether theee two subgtancesehouLd be authorized within  the Community,proposal for  a Council Directiveamending for  the seventh time the Directive of 23 October 1962 on the approximation  of the rules of  the Member States concerning the colouring matters authorized for  uee in  foodstuffs inttnded for  human consumptionTHE COUNCIL OF THE EUROPEAN  COM},IUNTTTES,AMENDED TEXTUnchangedUnchangedUnchangedUnchangedUochangedUnchangedUnehrngcdDeletedUnchangedUnchangedltr'or full  text  Eee oJ I{o. C 2OL, lO.g. Lg79, p.  +3-7- PE 62.070/tin.TEXT PROPOSED  BY THE COMMISSION  OFTHE EUROPEAN  COMMUNITIESHAS ADOPTED  TIIIS DIRECTIVE:Article  IThe Directive of  23 October 1962 ishereby amended as follows:1. The indenc in  Annex rI  referringto Brilliant  Blue FCF is  trans-ferred tc  Annex I  and insertedbetween E 132 and E 140 under thenumber E 1332. The following substances areadded to part  (B) of Annex II  under the condltione speciflcd:carraqeenan (exctueively for  thecolouring matt€rs listed  undernumben E 160 and E 16I ln  Annex I )Gum Arablc  (exclusively for  thecolourlng matterg lleted  undernumbera E 160 and E l6L in  Annex I)AMENDED TEXTArticle  IUnchangedDelet,edUnchanged3. Thg colouring matter yellow 2c is  Unchangeddeleted from part (A) of Annex IIfrom Lrqly  1980.Articles  2, 3 and 4 unchanged,  ," ,' ' Ittf:Y-8- PE 62.O7O/fLn.EXPLANATORY STATEMENTI.  INTRODUCTTON1.  The aim cf  this  proposed amendment  is  to  subject to  further  regulationthe use of colouring matters in  foodstuffs on the basis of recent scientlficfindings.  The following specific  proposals afe made:a.  to permit the use of  carrageenan and gum arabic as diluents onlytemporarily for  carotenoid colouring maLters,b.  to delete (=ban) colouring matter Yellow 2G from Ann€x II  of thebaElc directive,  the ban to take effect  only as from I  July 1980,c.  to authorlze definitlvely,  for  use in  the Community by inclusion inAnn€x I,  Srilliant  Blue FCF, one of the eubstances already permittedtemporarlly and thus figurlng  in  Annex II  of the basic directive,Z.  Annex I  of the basic directive  of  23.LO.62 liets  those colouring matterEauthorized dcfinitively  for  uge in  foodetuffg in  the Community whilst  AnnexII  lists  those col-ouring matters which are authorized  only temporariJ.y  byvlrtue  of certain  national statutory provisions.3.  The Commission's proposed amendments are.based on the opinions of theScientific  Committee for  Food published on 23 l[arch L979.  These opinionswere published in  the 8th Series of Reports sent to  Members on ll  October.II.  SPECIAL OBSERVATIONS4.  The committee takes the view that  the use of  chemical substances(colouring and flavouring agentg, etc.,)  in  foodetuffs for  humanconsumption must be approached with the greateet possible care,since the evidence ie  increaging  that  theee substances can haveadverso effecte  on health.  rn determining whether chemicalor other substances should be authorized for  use in  foodstuffs,several factors  such as toxicity,  allergic  reactions, technj-caIand economic requirements play an important role.-9- PE 62.o7O/tLn.r.  'ibre di-luents carrageenan and gum arabic are natural vegetablesubstances whffir already appear on the Community list  of  permittedemulsifiers,  stabil"izers,  thickeners and jelling  agents for  usein  foodEtuffg.  These diluents appear to be technically  necessarywhen certain carotenoid coJ-ouring matters are used in  some eoftdrinks.  since the commission is  engaged i-n a thorough reappraisalof all  diluents used in  col-ouring matters in  foodEtuffs, all  thatis  being asked for  is  temporary authorization for  the incl"usionof  these substances  in Annex II  under certain  conCitionso6.  The committee can aEree with this  proposal, but also wiehes to pointout that  gum arabic, according to a joint  FAo^fHO conmittee of  experts,can causo allergic  raactione (wHo liet  of  foodstuff additivesNo 5,  L976' pp"33L ffj.  The eoumittee therefore coneidere that  itwoui.l be both nppropriato  and nocassary, before the eubetance ledefinitlvoLy  approved, for  the sclentiflc  connnlttee for  Food todeLiver an opinion on the allergenic properties of  this  substance.7"  The colouring matter Yellow G2 was authorized until  I  January 1991,under the basic directive  of  L962, pending the outcome of  investigationsby the Scientific  Committee for  food.  Hot{ever, the substance is.  widely considered to be suspect, and is  already banned under nationallegislation  in various Medber States.  The permissible daily  dosage(p.d.d.)  is  very low at only l_,/lOomg per kg of body weight per day.8.  When thie  directive  waE amended for  the sj-xth time, the CommLttee  onthe Environnsnt, Public H€alth and Consumer Protection expreeeeddieappointment that there was stilL  no ban on the use of  this  colouringmatter (Doc. 455/77, p.5,  para 4).  Today the position  is  etillunchanged. There has been no further  research, owing to the lack. ofinterest  in the substance (see the report of  the Scientific  Corunitteefor  Food, eighth series,  1979, p.L2).  The committee poses the questionas to whether guidlines for  consumer prolection policy  shourd beDi.{sel- on Lne doubts and warnings of  the Committee  on the Environment,Public Haalth and Consumer protection,  or "the interests  of  industry.In this  case the suppoeed interests  of  industry seemed to have carriedmore weight than the interests  of the consumer.- 10- PE 62.o7o1'fLn.9. The cornmittee therefore absolutely  agrees with a ban on Yello$t c2and urgae that  it  be implemented as quickly as possible.10.  As regarde colouring matter Brilliant  Blue l.CF it  ls  proposedthat  its  lrse can be permitted within  the Community  until  1981where already permitted by national  legislation.  Its  uge isnot permitted in  most Menber States.  It  may only be usedin  the United Kingdom, IreLand and Denmark in  limited quantities.11.  There are alEo varying opinions on the toxicity  of this  substance,as is  clear from, for  instance, the great dj-fferences in  theprovisione banning the substance both in  EEc and non-EEC countriee.In  1975 the Scientific  Conmittee fixed  the p.d.d.  of  the subgtanceprovlslonally  at o to  2.5m9 per kg of body weight per day.  Accordingto recent reeearch (see elghth seriee of reporte of  the ScientificCommlttee, L979 p.11) human tolerance levele are higher, and itls  accepted that  the p.d.d.  can be fixed at O to  12.5mg per kg ofbody welght per day.  The reaponsible departments of wHo and FAocame to  comparable conclueions.L2.  The Committee  on the Environment, Public ltealth and Consumer Protectionwishes tomake the following marginal conments:(a) Brilliant  BI-ue has been clearly  shown to cause cancer, wheninjected eubcutaneously into  ercperimental  animals, at the pointof  injection.  This research wae carried out in  the early 5orsand is  degcribed in  a recent report by the lnternational  Agencyfor  Cancer Research (Iilonographs on the evaluation of  carcinogenicrisk  of  chemicals to man, part  16, p.18O, 1978).(b) Among ecientietE it  is  generally believed however that  asubstance which is  carcinogeni-c when injected subcutaneouslyie not necessarl,ly unaeceptable for  oral  conaumption providedthat metabollc  te6ts have clearly  ahown that  it  ie  not absorbed,or Is  abeorbed ln  lnsignificant  anounta by the alimentary canaland has no harmfuL effectg  on it.(c) The Scientific  Committee  on Food recently investigated this  pointand concluded in  its  eighth report in  1979 that  tests  on threespecies of  animal-s showed that  Brilliant  BIue was not absorbedby the intestineg,  and that  the same could be expected to applyto humans.- IT- PE 62.O7OtfLn.(d) The committee is,  however, of  the opinion that  the fact  thatthig  gubstance is  carcinogenic when inject,ed subcutaneously makeeit  impossible to rule  out carcinogenic reactions if  abeorption bythe inteetlnee takes place when the subgtance ie  taken orally.(e) The rnetabolic teete described by the Scientific  Comnitteew€r€ caruied out on healthy animals.  The rate of  intestinalabsorption can, however, take place under different  circumgtancesin  humans; people may be suffering  from infections  or irritations  ofthe intestinal  lining,  or be taking certain medicined (4.9.  laxatives)or foodetuffs (purgatives).(f)  In viaw of  theee considerations  the coumittee takes the vier,v thatbriiliant  blue FCF can in  fact  be described as toxicologicallyacceptable but should not therefore be designated 'completelysafe' .(g) There is  therefore good reaaon to ask what preesj-ng  economicand technlcal reasons exigt  for  the use of  this  eubstance,  andthe connnittee regrets that  the Commieslon's propoeal issilent  on thig  aepect.(b) The Conrmittea considers that  since the substance ie  notentirely  free of risk,  the economic  and technical need must beproved overwhelmingly,  and requests the conmittee to  clarify  thisaspect of the matter.(i)  The Committee on the Environment, Public Health and ConsumerProteetion is  prepared to give a favourable opinion onrestricted  and carefully  specified use of this  substance ifthe need for  it  is  pos.itively demonstrated.'".1- In connection with the above considerations  the conunittee urges thecommisgion, when submitting proposals for  directives  and proposalsfor  the anendment of directives  of  thie  kind,  not to confine j-tselfto toxicological  factors but to take ascount of  allergy  factors butlnd tcchnical and economic argumente as Frell,  ain^c6 each of  thee6factorr  ean play an important if  not a deciveive role  in  reachinga political  decieionr €€pecially in  dubious cases.-L2- PE 62.O7O/fLn.L4.  The committee  COnsiders it  important for  the consumer to betreated as a mature aduLt and again urges that  colouring anddlLuting agents used ehould be listed  on foodEtuff packagelabele in  the conaumer's ovrn language. The committee aLsoconsidere harmonization  of  foodetuff  labelling  to be a matterof gome urg€ncy so that thein one country as he is incompetition.consumer will-  be taken as eeriouslyanotherr Btld to  safeguard fair15.  Finally  the conmittee notes that  since 1962 various amendmentshave been made to the original  directive  so that  an overallview of the situation  as regards colouring matters which arenot permitted for  uEe in  foodstuffs has become sbme$that distorted'It  therefore considers it  a matter of  some importance for  theconmittee to give such an overall  view when it  next submitsproposalsforamendmente,possiblyintheformofanannexto the ProPosal.-13- PE 52.o7o/ ttn

Report drawn up on behalf of the Committee on the Environment, Public Health and Consumer Protection on the proposal from the Commission of the European Communities to the Council (Doc. 479/75) for a Directive amending for the seventh time the Council Directive of 23 October 1962 on the approximation of the rules of the Member States concerning the colouring matters authorized for use in foodstuffs intended for human consumption. Working Documents 1979-1980, Document I-834/79, 8 March 1980

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